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This book covers all ethical aspects of introducing novel implants and procedures in neurosurgery in a structured way, addressing the current knowledge gap concerning ethical innovations in neurosurgery. Initially it explores the difficulties involved in defining when a procedure should be considered innovation, research, or care. To this end, it presents not only an overview of current literature, but also data from a recent survey among neurosurgeons in Europe.
The book subsequently discusses the ethical issues related to innovation. These include: informed consent (what should a surgeon tell the patient and how should he/she do so), oversight (can any surgeon simply implant a novel spinal device?), the learning curve (when should a surgeon be allowed to perform a novel procedure?), vulnerable patients (how to innovate in the pediatric population or in an emergency setting), and conflicts of interest, as well as the ethics of paying for innovative treatments.
In turn, the closing chapters focus on the evaluation of neurosurgical research and innovation. Are cultural changes necessary and how could innovation benefit from (international) collaborations? Given the range of topics addressed, the book offers neurosurgeons, residents, scientists, companies and hospital administrations a valuable guide to introducing novel implants and techniques in neurosurgery.
Marike Broekman, M.D. Ph.D. L.L.M. is a neurosurgeon with a focus on neuro-oncology at Haaglanden Medical Center/Leiden University Medical Center, the Netherlands and holds appointments at the Department of Neurology at Massachusetts General Hospital/ Harvard Medical School Boston, USA. Dr. Broekman is the principle investigator of a laboratory focusing on the development of innovative treatments and techniques for the diagnosis of brain tumors. She is the current president of the Ethico-Legal Committee of the European Association of Neurosurgical Societies and a member of the Ethics Committee of the World Association of Neurosurgical Societies. Dr. Broekman has published over 80 papers in peer-reviewed journals, and is a member of the editorial board of Acta Neurochirurgica.
Part I Innovation in Neurosurgery: Key Ethical Challenges.- 1. Defining Innovation in Neurosurgery: Challenges and Implications.- 2. Informed Consent for Neurosurgical Innovation.- 3. Ethical Challenges of Current Oversight and Regulation of Novel Medical Devices in Neurosurgery.- 4. Ethics of Neurosurgical Innovation: Oversight and Regulation.- 5. The Ethics of the Learning Curve in Innovative Neurosurgery.- 6. Innovation in Pediatric Neurosurgery: The Ethical Agenda.- 7. Conflict of Interest in Neurosurgical Innovation.- Part II Payment for and Right to Innovation in Neurosurgery.- 8. The Ethics of Funding Innovation: Who Should Pay?.- 9. Public Pressure for Neurosurgical Innovation.- 10. Surgical Innovation for Terminal Illnesses: Do Patients have a Right to Access Innovative Treatments?.- 11. Ethics Committees, Innovative Surgery, and Organizational Ethics.- Part III Evaluation of Innovations in Neurosurgery.- 12. Evaluating Awake Craniotomies in Glioma Patients: Meetingthe Challenge.- 13. Ethical Considerations of Neuro-Oncology Trial Design in the Era of Precision Medicine.- 14. The Ethics of Passive Data and Digital Phenotyping in Neurosurgery.- 15. Research Ethics: When Innovation is Clearly Research.- Part IV Innovation in Neurosurgery: Required Culture and Team Collaboration. 16. Innovation and Team Collaboration in Neurosurgery.- 17. Culture and Attitudes Supporting Ethical Innovation in Neurosurgery.- 18. Perspective: Future of Innovation in Neurosurgery.
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